GigaGen has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS). 4 October 2024
Oxford, UK-based Enara Bio today announces the closing of a $32.5 million Series B financing supported by a strong syndicate of new and existing biotech investors. 3 October 2024
Zenas BioPharma announced the pricing of its upsized initial public offering of 13,235,294 shares of its common stock at an initial public offering price of $17.00 per share. 13 September 2024
US pharma major Eli Lilly and Egyptian firm EVA Pharma have entered into an agreement to expand access to Olumiant (baricitinib) to an estimated 20,000 people in 49 low- to middle-income countries in Africa by 2030. 6 September 2024
Japan’s Eisai and US biotech Biogen today revealed that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved Leqembi (lecanemab) for the treatment of Alzheimer’s disease (AD). 14 August 2024
US clinical stage caner drug developer Theriva Biologics revealed that the US Food and Drug Administration (FDA) has granted Rare Pediatric Drug designation (RPDD) for VCN-01 for the treatment of retinoblastoma. 1 August 2024
Eisai and Biogen have announced that Israel has approved their Alzheimer's treatment, Leqembi (lecanemab), adding to nods in the USA, Japan, China, South Korea, and Hong Kong. 12 July 2024
Contract research and development organization (CDMO) Emergent BioSolutions has announced that Johnson & Johnson will pay $50 million to resolve claims linked to a terminated manufacturing deal for the latter’s COVID-19 vaccine. 11 July 2024
Japan’s Eisai and US biotech Biogen have announced that the Department of Health in Hong Kong has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) for treatment of Alzheimer’s disease (AD). 11 July 2024
PolTREG, a Polish biotech developing cell therapies for autoimmune diseases, has announced that its polyclonal Treg cell therapy PTG-007 demonstrated significant insulin secretion restoration in early-onset type-1 diabetes (T1D) patients, as well as a longer period of disease remission compared to a control group receiving standard-of-care. 24 June 2024
Indian drugmaker Cipla announced that its wholly-owned subsidiary in the UK, Cipla (EU) Limited, will invest an additional 3 million euros ($3.2 million) in Ethris GmbH, a German firm delivering mRNAs directly to the respiratory system. 19 June 2024
Dutch autoimmune diseases specialist Argenx announced that results from the Phase II ALPHA study of efgartigimod in post-COVID-19-mediated postural orthostatic tachycardia syndrome (PC-POTS) show that treated patients had no clinically meaningful improvement compared to placebo on the total Malmö POTS symptom (MaPS) score and COMPASS31. 17 June 2024
The US Food and Drug Administration (FDA) has accepted Eisai’s supplemental Biologics License Application (sBLA) for monthly Leqembi (lecanemab-irmb) intravenous (IV) maintenance dosing. 10 June 2024
The European Medicines Agency (EMA) has approved a Type II variation to the Summary of Product Characteristics (SmPC) for its approved Chimeric Antigen Receptor (CAR) T-cell therapies, Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) from Gilead Sciences’ Kite subsidiary. 6 June 2024
Cell and gene specialist Orgenesis has entered into a preliminary, non-binding term sheet with Leidos to develop and potentially obtain US marketing approval of ranpirnase for the systemic treatment of patients with SARS-CoV-2, the virus that causes COVID-19. 22 June 2020
US immuno-oncology (I-O) focussed biotech Agenus saw its shares advance 6% pre-market today, following the announcement of an out-licensing deal, but lost the gains by mid-morning. 22 June 2020
French pharma major Sanofi’s investigational enzyme replacement therapy (ERT), avalglucosidase alfa met the primary endpoint demonstrating non-inferiority in improving respiratory muscle strength, as measured by using percent-predicted forced vital capacity (FVC) in the upright position, compared to alglucosidase alfa (standard of care) in patients with late-onset Pompe disease (LOPD). 22 June 2020
The British biotech industry has released a new report indicating the resilience of the sector under the challenging conditions of the coronavirus pandemic. 22 June 2020
The European medicines regulator is to review a bid from Germany’s Merck KGaA and New York’s Pfizer to extend the marketable use of Bavencio (avelumab). 22 June 2020
British cell therapy specialist Rexgenero has bought all the key assets of Paris-based immunotherapy company aratinga.bio, a preclinical-stage firm developing an off-the-shelf CAR-T cell therapy. 22 June 2020
Ascentage Pharma over the weekend announced a clinical collaboration with Acerta Pharma, the hematology R&D subsidiary of UK pharma major AstraZeneca. 22 June 2020
Miami, USA-based Ridgeback Biotherapeutics has initiated two Phase II clinical trials to test the efficacy of EIDD-2801 as an anti-viral treatment for COVID-19. 22 June 2020
The US Food and Drug Administration will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to review data supporting the Biologics License Application (BLA) for belantamab mafodotin on July 14. 20 June 2020
The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Tazverik (tazemetostat) in two follicular lymphoma (FL) indications. 19 June 2020
China’s National Medical Products Administration (NMPA) has approved Dupixent (dupilumab) for moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. 19 June 2020
Mixed results for Swiss pharma giant Roche show the Phase III IPATential150 study met one of its co-primary endpoints, while missing the other. 19 June 2020
The US Food and Drug Administration has approved Crysvita (burosumab-twza) injection to treat patients age two and older with tumor-induced osteomalacia (TIO), a rare disease that is characterized by the development of tumors that cause weakened and softened bones. 19 June 2020
Two subsidiaries of Japan’s Sumitomo Dainippon Pharma, Urovant Sciences and Sunovion Pharmaceuticals, have teamed up to work on the launch of vibregon. 19 June 2020
Seattle, USA-based biotech Alpine Immune Sciences saw its shares rocket 170% pre-market after announcing its biggest deal yet, with AbbVie, for an exclusive worldwide option and license agreement for ALPN-101, a first-in-class dual CD28/ICOS co-stimulation antagonist. 18 June 2020
Chicago-based AbbVie has released positive data from the Phase III MEASURE UP 1 study of Rinvoq (upadacitinib) in moderate to severe atopic dermatitis. 18 June 2020
The marketing authorization application (MAA) for Brukinsa (zanubrutinib) to treat Waldenström’s macroglobulinemia (WM) patients who have received at least one prior therapy or as first-line treatment for those unsuitable for chemo-immunotherapy has been validated for regulatory review by the European Medicines Agency (EMA). 18 June 2020
UK respiratory disease focussed biotech firm Synairgen has announced the expansion of the placebo-controlled home setting clinical trial of SNG001 (inhaled formulation of interferon-beta-1a) in patients with COVID-19. 18 June 2020
Swiss pharma giant Roche has announced positive results from the Phase III IMpassion031 study, evaluating Tecentriq (atezolizumab) plus chemo in triple-negative breast cancer (TNBC). 18 June 2020